HomeGermanyWILAMED GMBH

WILAMED GMBH

Germany · Kammerstein
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Saudi Arabia, Canada, Singapore, South Korea, Australia, Israel — 7 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
7listed device types
Class I 2Class II 4Class III 0unclassified 1
plus 7 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
4 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
10active ARTG entries
Class I 2IIa 7IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States7 registration records, 0 510(k), 0 PMA
Saudi Arabia1 confirmed, 0 excluded
Manufacturer names merged into this page: WILAMED GMBH · wilamed GmbH

Company information

Country
Germany
City
Kammerstein

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA listed device types

Continuous, Ventilator, Home Use 1Humidifier, Respiratory Gas, (Direct Patient Interface) 1Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer 1Ventilator, Continuous, Facility Use 1Airway, Oropharyngeal, Anesthesiology 1Support, Breathing Tube 1Respiratory Humidifier For Emergency Use 1

Registration details (sample)

MarketIdentifierNameClass / date
SAME0000005670SFDAA00001WILAflow G2 Headgear

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